A Search for Helicobacter Pylori in Localized Vulvodynia

This study has been completed.
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
First received: July 13, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
Hypothesis: to examine a possible association between localized vulvodynia and H. pylori infection.

Vulvar Vestibulitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Laboratory and Clinical Search for the Presence of H. Pylori and Treatment Against it in Localized Vulvodynia (Vestibulitis, Vestibulodynia).

Resource links provided by NLM:

Further study details as provided by Western Galilee Hospital-Nahariya:

Enrollment: 27
Study Start Date: May 2004
Study Completion Date: June 2007
Detailed Description:

Subsequent sections from the paraffin blocks were prepared and stained by modified Giemsa. Immunostaining for H. pylori was done as described. In short, tissue sections were deparaffinized in xylene, rehydrated through decreasing concentrations of alcohol ending in phosphate-buffered saline (PBS), and subjected to pretreatment with Proteinase K (8 minutes). The sections were quenched with 3% hydrogen peroxidase, incubated with protein block for 15 minutes at room temperature, and washed in PBS. Tissues then were incubated with polyclonal rabbit anti-H pylori antibody (dilution, 1:10; clone ch-20 429, DAKO, Carpinteria, CA). Finally, sections were washed in 0.05% polysorbate 20 in PBS, pH 7.4, and the bound antibody was detected using streptavidin and biotinylated secondary antibody with diaminobenzidine as the chromogen. Sections were counterstained with hematoxylin, dehydrated, and mounted. Negative controls were sections treated as above, but instead of incubation with the primary antibody, they were incubated with 1% bovine serum albumin in PBS.

Vulvar biopsies of seven other women without localized vulvodynia served as healthy controls.

The positive and negative control gastric tissues for the immunohistochemical stain of the H. pylori microorganisms were obtained from the archives of the Department of Pathology.


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Paraffin blocks of vestibular tissues from patients with Vestibulodynia

Exclusion Criteria:

  • Patients without vestibulodynia
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00501774

Pathology Laboratory
Haifa, Israel
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Principal Investigator: Jacob Bornstein, MD westen Galilee Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00501774     History of Changes
Other Study ID Numbers: Sabo-1 
Study First Received: July 13, 2007
Last Updated: July 13, 2007
Health Authority: Israel: Ethics Commission

Keywords provided by Western Galilee Hospital-Nahariya:
Localized vulvodynia
Helicobacter pylori
peptic disease

Additional relevant MeSH terms:
Vulvar Vestibulitis
Genital Diseases, Female
Vulvar Diseases

ClinicalTrials.gov processed this record on May 26, 2016